Core Viewpoint - ANI Pharmaceuticals (ANIP) shares experienced a significant rally of 10.6% due to positive financial guidance for 2026, exceeding Wall Street expectations [1][2]. Financial Performance - ANI Pharmaceuticals projects total net revenues between $1.055 billion and $1.115 billion for the full year 2026, with approximately 60% of this revenue expected from its rare disease segment [2]. - The Zacks Consensus Estimate for total net revenues was $937.71 million, indicating a substantial positive outlook from the company [2]. Earnings Expectations - The company is anticipated to report quarterly earnings of $2.02 per share, reflecting a year-over-year increase of 23.9% [3]. - Expected revenues for the upcoming quarter are $233.91 million, which represents a 22.7% increase compared to the same quarter last year [3]. Stock Performance and Trends - The consensus EPS estimate for ANI has remained unchanged over the last 30 days, suggesting stability in earnings expectations [4]. - A stock's price typically does not continue to rise without trends in earnings estimate revisions, indicating the importance of monitoring ANIP's performance moving forward [4]. - ANI Pharmaceuticals holds a Zacks Rank of 2 (Buy), indicating a favorable outlook compared to other stocks in the same industry [4]. Industry Comparison - ANI Pharmaceuticals operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Arcutis Biotherapeutics, Inc. (ARQT), has seen a decline of 5.1% in its stock price recently [4]. - Arcutis Biotherapeutics has a consensus EPS estimate of $0.02, which is a 122.2% increase from the previous year, but it currently holds a Zacks Rank of 3 (Hold) [5].

Financial Projections - Total net revenue projected to exceed $1 billion in 2026, representing a year-over-year increase of over 26%[4] - Cortrophin Gel net revenue for 2025 reached $348 million, reflecting a 76% year-over-year growth[6] - Adjusted non-GAAP EBITDA for 2025 estimated between $221 million and $228 million, showing a growth of over 42% year-over-year[6] - Adjusted non-GAAP diluted EPS for 2025 projected between $7.37 and $7.64, indicating a year-over-year increase of over 42%[6] - 2026 adjusted non-GAAP gross margin expected to be between 59.3% and 60.3%[8] - The total revenue for 2026 is projected to exceed $1 billion, representing a 26% year-over-year growth[24] Product Performance and Growth - Rare Disease business expected to account for approximately 60% of total revenues in 2026[4] - Cortrophin Gel anticipated to drive long-term growth by addressing unmet needs in nephrology, neurology, rheumatology, and pulmonology[7] - ILUVIEN net revenue for 2025 estimated at $75 million, with growth initiatives planned for 2026[6] - Rare Disease net revenues expected to grow significantly, with Cortrophin Gel and ILUVIEN contributing to this expansion[10] - Cortrophin Gel is expected to deliver over 60% year-over-year growth in 2026, contributing significantly to the company's revenue growth strategy[24] - The ACTH market is projected to reach approximately $992 million in 2025, reflecting a 45% year-over-year increase[11] Generics Business Strategy - Generics business projected to maintain a cadence of 10-15 product launches annually[7] - The company aims to launch 10-15 new products annually, investing a high single-digit percentage of Generics revenue into R&D[19] - The Generics business is expected to generate net revenues of $301 million in 2024, with a year-over-year growth rate exceeding 20%[19] - The Generics business has manufactured and supplied over 2.5 billion doses of therapeutics in the last 12 months[19] Market Research and Patient Insights - The addressable patient population for Cortrophin Gel includes approximately 285,000 patients for acute gout flares, with only 36% receiving treatment annually[13] - ANI Pharmaceuticals is focusing on expanding its addressable patient population for Cortrophin Gel, targeting conditions such as gout, multiple sclerosis, rheumatoid arthritis, sarcoidosis, and nephrotic syndrome[1] - The company has conducted extensive market research, indicating significant disease burden and treatment gaps in the U.S. for multiple sclerosis, with a prevalence rate of approximately 0.1%[5] - ANI's analysis shows that the burden of gout in the U.S. is substantial, with a notable percentage of patients experiencing frequent flares[3] - The company is actively exploring new treatment patterns for sarcoidosis, with recent studies highlighting variability in disease management across the U.S.[16] - ANI is leveraging data from multiple studies to inform its strategies for addressing steroid-resistant nephrotic syndrome, which remains a challenging area in pediatric care[21] - The company aims to enhance its product offerings by focusing on innovative therapies for chronic diseases, as indicated by its ongoing research initiatives[17] - ANI is committed to improving patient outcomes through targeted therapies, as evidenced by its focus on conditions with high unmet medical needs[19] - The company is analyzing treatment patterns and patient insights to refine its approach to managing rheumatoid arthritis, particularly in patients with low disease activity[11] - ANI's market research indicates a growing prevalence of sarcoidosis, necessitating new treatment strategies to address patient needs effectively[15] - The company is positioned to capitalize on the increasing demand for effective therapies in chronic disease management, supported by its comprehensive data analysis and research efforts[18]

Corporate Presentation January 2026 © 2026 ANI Pharmaceuticals, Inc. 1 Disclaimers Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Act, and Section 21E of the Securities Exchange Act of 1934, as amended. The guidance included herein is from or supplemental to the Company's press release on January 12, 2026. The Company is neither reconfirming this guidance as of the date of this investor presentation nor assuming any obligation to upd ...

Core Insights - ANI Pharmaceuticals, Inc. reported significant growth in 2025, with total net revenues increasing by at least 39% and adjusted non-GAAP EBITDA growing by at least 42% [2] - The company anticipates generating over $1 billion in total net revenues for 2026, with approximately 60% coming from its Rare Disease business [2] - ANI plans to expand its Rare Disease organization to capture opportunities in acute gouty arthritis flares, a unique indication for Cortrophin Gel [2][12] Financial Performance - Preliminary results indicate Cortrophin Gel net revenues of approximately $111.4 million for Q4 2025, an 88% increase year-over-year, and approximately $347.8 million for the full year 2025, a 76% increase year-over-year [3] - Full year 2025 total net revenues are expected to be between $854 million and $873 million, with adjusted non-GAAP EBITDA between $221 million and $228 million [4][7] - The company expects full year 2026 total net revenues of $1,055 million to $1,115 million, with Cortrophin Gel net revenues projected at $540 million to $575 million [7][8] Strategic Priorities - ANI aims to maximize the growth opportunity for Cortrophin Gel by addressing unmet medical needs across various indications [12] - The company will focus on expanding its Rare Disease organization and advancing a Phase 4 clinical trial for Cortrophin Gel in acute gouty arthritis flares [12] - Continued execution in the Generics business is expected to support cash generation for the Rare Disease segment [2][12]

Core Viewpoint - ANI Pharmaceuticals, Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, highlighting its commitment to developing innovative therapeutics [1]. Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing high-quality therapeutics [3]. - The company aims to deliver sustainable growth through its Rare Disease business, Generics business, and Brands business, targeting areas such as ophthalmology, rheumatology, nephrology, neurology, and pulmonology [3].

Core Insights - ANI Pharmaceuticals' stock has increased by 21% over the past six months due to strong financial performance in the first nine months of 2025, with Q3 results exceeding expectations in both sales and earnings [2][9] - The company has raised its full-year 2025 guidance, indicating management's confidence in operational consistency [2][3] Financial Performance - ANI Pharmaceuticals now anticipates full-year sales between $854 million and $873 million, an increase from the previous estimate of $818 million to $843 million, and expects EPS in the range of $7.37 to $7.64, up from $6.98 to $7.35 [3] - This updated guidance reflects an annual growth of 39-42% in sales and 42-47% in earnings [3] Rare Disease Segment - The rare disease franchise has contributed $291 million to revenue in 2025, more than doubling compared to the previous year, primarily driven by demand for Cortrophin Gel [4] - Sales of Cortrophin Gel surged by 70% year over year to $236 million in the first nine months of 2025, with expectations to reach between $347 million and $352 million by year-end, reflecting a 75-78% increase [5] Generics Business - The generics segment saw a 27% year-over-year revenue increase to over $283 million in the first nine months of 2025, supported by healthy core volumes and new product launches [8] - However, the company anticipates a decline in generics revenues due to increased competition in the fourth quarter [9][10] Market Position and Valuation - ANI Pharmaceuticals' stock has outperformed the industry, with a 45% increase over the past year compared to the industry's 15% growth [11] - The stock currently trades at a price/sales (P/S) ratio of 2.01, lower than the industry average of 2.43, indicating a potential for further upside [13] Future Outlook - The company is expected to maintain momentum in its rare disease portfolio and continue growth in its ophthalmology products, positioning it for sustained profitability [15][16] - Estimates for ANI Pharmaceuticals' EPS for 2025 and 2026 have increased over the past 60 days, reflecting positive market sentiment [17]

Core Insights - ANI Pharmaceuticals' rare disease franchise, particularly the ACTH-based injection Cortrophin Gel, has driven significant growth in 2025, with sales increasing by 70% year over year to $236 million in the first nine months [1][8] - The company anticipates that its rare disease business will account for half of its total net revenues in 2025, with Cortrophin Gel sales projected to reach between $347 million and $352 million, reflecting a year-over-year growth of 75-78% [3][8] Sales Performance - Cortrophin Gel's sales growth is supported by an expanded sales force in neurology, rheumatology, and nephrology, as well as synergies from the integrated ophthalmology sales team [1] - The third quarter saw continued growth in prescriptions for the prefilled syringe, which constituted approximately 70% of newly initiated cases, with acute gouty arthritis flares being a significant contributor, accounting for over 15% of overall Cortrophin Gel utilization [2] Competitive Landscape - ANI's ophthalmology products, Iluvien and Yutiq, face competition from major pharmaceutical companies such as AbbVie and Regeneron, with AbbVie's Ozurdex and Regeneron's Eylea being direct competitors [5][6] - The primary competitor to Cortrophin Gel is Acthar Gel, marketed by Keenova Therapeutics, which has also raised its sales outlook for 2025, now expecting growth of 30-35% [6] Financial Performance - ANI Pharmaceuticals' shares have increased by 42.3% over the past year, outperforming the industry growth of 17.6% [7] - The company is currently trading at a premium valuation, with a price/sales (P/S) ratio of 2.04, compared to the industry average of 1.92 [9] Earnings Estimates - EPS estimates for 2025 and 2026 have seen upward revisions over the last 60 days, indicating positive market sentiment [11]

Core Insights - Stonepine Capital Management has fully exited its position in ANI Pharmaceuticals, selling 38,597 shares for a total of $2.52 million, marking a complete divestment as of September 30 [2][3][6] Company Overview - ANI Pharmaceuticals has a market capitalization of $1.85 billion, with a trailing twelve months (TTM) revenue of $826.89 million and a net income of $40.57 million [5] - The company's stock price as of the latest report is $82.41, reflecting a 49% increase over the past year, significantly outperforming the S&P 500, which has risen about 15% in the same timeframe [4] Business Performance - In the third quarter, ANI Pharmaceuticals reported a 54% year-over-year revenue increase to $227.8 million, with adjusted EBITDA rising nearly 70% to $59.6 million [12] - The company has raised its full-year revenue guidance to a range of up to $873 million and adjusted EBITDA to as much as $228 million, with rare disease therapies expected to contribute approximately half of total sales by 2025 [12] Market Position - ANI Pharmaceuticals operates as a specialty and generic drug manufacturer, focusing on controlled substances, oncology products, hormones, steroids, injectables, and oral solid dose formulations [8][9] - The company serves a diverse customer base, including retail pharmacy chains, wholesalers, distributors, mail order pharmacies, and group purchasing organizations across the U.S. and Canada [9][10] Strategic Insights - The exit by Stonepine Capital Management appears to be a capital rotation rather than a lack of confidence in ANI Pharmaceuticals, as the fund's remaining holdings are more focused on earlier-stage biotech companies [13] - ANI's fundamentals remain strong, with future returns likely dependent on sustained growth in rare disease therapies and maintaining margin discipline rather than relying on multiple expansions [13]

Industry Overview - The biotech sector has shown a strong recovery in 2025, with the Nasdaq Biotechnology Index rising by 33.1% year to date after bottoming out in April 2025 due to potential steep tariffs impacting the pharma and biotech sectors [1][2] - Key drivers of this rally include new drug approvals, a positive pipeline, regulatory updates, and a surge in mergers and acquisitions (M&A) activity, with the FDA approving over 42 drugs so far this year [2][3] M&A Activity - The year has seen a significant increase in M&A activity, driven by the changing landscape and focus on AI-driven drug discovery, as large pharmaceutical and biotech companies seek to expand and diversify their product portfolios amid rising generic competition [3] Regulatory Agreements - The Trump administration has signed agreements with major pharma and biotech companies, including Gilead Sciences, Amgen, Merck, and Novartis, aimed at lowering prescription drug prices for chronic conditions [4] - These companies are expected to collectively invest at least $150 billion in domestic production in the near term, indicating a commitment to innovation in medical treatments [5] Company Highlights EyePoint, Inc. (EYPT) - EYPT focuses on developing innovative therapeutics for serious retinal diseases, with its lead candidate, Duravyu, being evaluated in late-stage studies for wet age-related macular degeneration [7][11] - EYPT's shares have surged by 140.5% in 2025, with a current average target price of $34.18 representing an upside of 100.35% [12] ANI Pharmaceuticals (ANIP) - ANIP is a diversified biopharmaceutical company with a strong focus on rare diseases, particularly through its ACTH-based injection, Cortrophin Gel, which saw sales jump by 70% year over year to $236 million in the first nine months of 2025 [13][14] - The stock has gained 52.9% over the year, with a current average target price of $109.25 representing an upside of 31.9% [16] Tango Therapeutics (TNGX) - Tango Therapeutics is focused on precision oncology, developing treatments based on synthetic lethality for specific tumors, with promising pipeline candidates including PRMT5 inhibitors for various cancers [17][19] - TNGX shares have increased by 163.8% in the past year, with a current average target price of $13.22 representing an upside of 56.26% [21]

Core Insights - The biotech industry has shown strong performance in 2025 despite macroeconomic uncertainties, driven by new drug approvals and pipeline progress [1][2] - Mergers and acquisitions (M&A) have surged in 2025, with large companies expanding their portfolios through strategic collaborations and acquisitions [2][9] - Smaller biotech firms leveraging breakthrough technologies are gaining attention, contributing to overall sector momentum [2] Industry Overview - The Zacks Biomedical and Genetics industry includes biopharmaceutical and biotechnology companies that develop innovative drugs using advanced technologies [4] - The industry has outperformed both the Zacks Medical sector and the S&P 500, with a 22.1% gain over the last six months compared to 12.5% and 16.5% respectively [18] - The current valuation of the industry, based on the trailing 12-month price-to-sales ratio, is 2.47X, lower than the S&P 500's 5.96X and the Zacks Medical sector's 2.66X [19] Trends and Challenges - Key trends shaping the industry include a focus on innovation, the use of AI in drug discovery, and the rise of precision medicine [6][12] - Successful commercialization remains a challenge for smaller biotechs, often leading to collaborations with larger firms for shared sales or royalties [7] - Pipeline setbacks and potential tariffs pose risks, as developing drugs is costly and time-consuming, with many therapies taking years to gain approval [13][14] Notable Companies - Amicus Therapeutics has seen strong performance with its lead drug Galafold, which is approved for Fabry disease, and has settled patent litigation to fend off generic competition [21][22] - ANI Pharmaceuticals has a diversified focus on rare diseases and generics, with a notable 70% year-over-year sales increase for its ACTH-based injection [23][24] - Arcutis Biotherapeutics is focused on treating inflammatory skin diseases, with its lead product Zoryve performing well and expanding its label [25][26] - Tango Therapeutics is developing precision medicine for oncology, with promising data from its ongoing studies [27][28] - Pacira BioSciences is expanding its lead drug Exparel's label and has seen a 36.4% gain in shares over the past year [29][30]